BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 4954543 · Received July 30, 2015

    Report

    Report Number
    3004962788-2015-00052
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 2, 2015
    Report Date
    September 10, 2015
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PREVENTATIVE MAINTENANCE SERVICE CALL WAS PERFORMED AT THE SITE AND THE EVALUATION COULD NOT IDENTIFY ANY ANOMALIES. SUPERDIMENSION HAS REQUESTED A COMPONENT OF THE DEVICE, CASE RECORDINGS, FOR EVALUATION BUT HAS NOT RECEIVED ANYTHING TO DATE. OUT OF AN ABUNDANCE OF CAUTION, SUPERDIMENSION IS FILING THIS MDR DUE TO THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(6) 2015 DATE OF FOLLOW-UP REPORT: (B)(6) 2015. A COMPONENT OF THE SUPERDIMENSION SYSTEM, CASE RECORDINGS WERE RETURNED AND EVALUATED. THE ROOT CAUSE COULD NOT BE DETERMINED AND NO EVIDENCE FOUND OF A SYSTEM MALFUNCTION.

    Description of Event or Problem · 1

    DURING A SUPERDIMENSION CASE THE PHYSICIAN DID NOT THINK THE SYSTEM WAS ACCURATELY NAVIGATING TO THE TARGET LESION. DUE TO THIS INACCURACY THE CASE WAS ABORTED AND NOT COMPLETED BY OTHER MEANS. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND EXPERIENCED NO COMPLICATIONS. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498374 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20

    Patients

    Seq Age Sex Outcome Treatment
    1